Proven Impact in Quality and Regulatory Transformation





At Datod Consulting, we bring over three decades of global quality leadership to help life science and diagnostics organisations achieve operational excellence, regulatory compliance, and measurable efficiency gains.



Our consulting work and leadership experience have consistently delivered results across the medical device and in vitro diagnostics sectors — from complex global transformations to focused process improvements.


Selected Achievements


Global Quality Transformation


  • Delivered multi-site Quality Management System (QMS) remediation and improvement plans across global operations.
  • Unified multiple quality systems under a single regulatory framework, simplifying compliance and driving standardisation.
  • Successfully led the rollout of a global electronic QMS (eQMS) platform, improving process efficiency by over 30%.


Operational Efficiency & Cost Optimisation


  • Partnered with multinational diagnostics organisations to streamline risk, design control, and CAPA processes.
  • Achieved multimillion-dollar savings through workforce optimisation and process redesign — without compromising regulatory standards.
  • Delivered measurable improvements in audit readiness, inspection performance, and product quality outcomes.


Regulatory & Compliance Leadership


  • Oversaw successful regulatory inspections and audits across multiple regions.
  • Developed and implemented global policies in change control, risk management, and root cause analysis.
  • Supported regulatory submissions and manufacturing clearances worldwide.


Strategic Growth Enablement


  • Designed regulatory frameworks to support entry into emerging health technology markets.
  • Guided large-scale site relocations and offshoring programs while maintaining product continuity and compliance.





Beyond Compliance — Building Capability



Our focus extends beyond fixing problems. We help organisations build resilient, scalable systems that empower teams, reduce bureaucracy, and unlock innovation.


Through Datod Consulting and leadership roles in global diagnostics organisations, we’ve consistently delivered:


  • Improved compliance maturity
  • Enhanced operational efficiency
  • Reduced organisational complexity
  • Sustainable cultural change


Thought Leadership


  • Datod Consulting’s approach is grounded in real-world experience and proven frameworks.
    Our work has been featured in:
  • Transforming Quality Organizations: A Practical Guide (Business Expert Press, 2023)
  • The CAPA Paradox and The Change Dilemma (Lulu.com, 2025)
  • Untangle: Release Your Organisation from Bureaucracy (Lulu.com, 2025)


Let’s Simplify Quality Together



  • Whether you’re scaling a quality system, preparing for an audit, or seeking to improve cross-functional performance - Datod Consulting provides practical, executive-level support to help you move faster with confidence.
  • Contact us today to learn how we can help you achieve lasting transformation.